MAUDE Adverse Event Report: CORDIS US CORP. INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 538493

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 4f infiniti diagnostic catheter separated in two pieces.The device was broken near the hub.The broken segment was still outside the patient and was retrieved.The entire product was able to be removed with nothing left behind.Another infiniti catheter was used to get the diagnostic heart catheterization procedure completed.There was no reported patient injury.It was during the second injection.A 4f non-cordis sheath was used.There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected, and prepped according to the instructions for use (fu).The target lesion was reported to be the left main coronary artery (lca).Lesion calcification is unknown; there was no vessel tortuosity and the percentage stenosis is unknown.The device was not used for a chronic total occlusion (cto).There was no unusual force necessary during use of the device and no resistance/ friction experienced during any part of the procedure.There was no resistance met while advancing the device.Excessive torquing was not required.The tip was visible on fluoroscopy throughout the procedure.The device was returned for evaluation.

• Brand Name: INFINITI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18992822
• MDR Text Key: 338881293
• Report Number: 9616099-2024-00092
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032014953
• UDI-Public: 10705032014953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 538493
• Device Lot Number: 18271174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEART CATH WITH 4 F TERUMO SHEATH
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 94 KG